This Week in Managed Care: May 15, 2020

Dr Fauci warns of unnecessary deaths if COVID-19 restrictions are lifted too quickly, a rare inflammatory disease emerges in children with COVID-19, and a novel cell replacement treatment shows promise in Parkinson disease.

Welcome to This Week in Managed Care, I’m Matthew Gavidia.

Fauci, Task Force Discuss Federal Response to COVID-19

This week, members of the White House Coronavirus Task Force testified before the Senate Health Committee to discuss the federal response to the pandemic and reopening the country.

The nation’s top infectious disease expert, Dr Anthony Fauci, said the more than 80,000 American deaths attributed to COVID-19 likely is an underestimate.

If social distancing measures are not phased out gradually, Fauci said, “There is a real risk that you will trigger an outbreak you may not be able to control… not only leading to some suffering and death that could be avoided but could even set you back on the road to…economic recovery. It would almost turn the clock back rather than going forward.”

Fauci laid out the National Institutes of Health’s 4-point plan to combatting the pandemic:

• Improve fundamental knowledge of the virus and the disease it causes.
• Develop new point-of-care diagnostics.
• Characterize and test therapeutics.
• And develop safe and effective vaccines.

Some states have already begun loosening social distancing guidelines, overlooking the phased approach developed by the CDC and reportedly shelved by the White House last week.

For more, visit ajmc.com.

Study Details Inflammatory Disease Affecting Children With COVID-19

Recent reports of children contracting—and occasionally dying—from a rare inflammatory disorder associated with COVID-19 have prompted concern, as the disease historically has had minor impacts on pediatric populations.

Although not identical, symptoms of pediatric multisystem inflammatory syndrome, or PMIS, resemble those of a rare childhood illness called Kawasaki disease, which predominately affects children under the age of 5.

An observational cohort study published this week in The Lancet offers the first detailed reports of 10 patients from the Bergamo province of Italy who exhibited symptoms of PMIS.

Overall, monthly incidence of the disease was “at least 30 times greater than the monthly incidence of the previous 5 years and has a clear starting point after the first case of COVID-19 was diagnosed in our area," authors said. Moreover, those diagnosed recently experienced more severe cases of the condition.

However, authors stress the complication remains very rare and that most infected children, if they receive appropriate hospital care, will make a complete recovery.

For more, visit ajmc.com.

FDA Broadens Authorization of Saliva-Based COVID-19 Test

Last Friday, the FDA expanded the authorization of the first diagnostic test for COVID-19, that uses saliva samples people collect at home.

Statements from both the FDA and test developer Rutgers Clinical Genomics Laboratory say this expanded use will allow for more widespread testing and increase safety for both the public and health care professionals, who will be spared the need for invasive testing procedures on patients.

According to a statement from FDA, this step “builds on last month’s EUA for the first diagnostic test with a home-collection option,” which used a sample obtained from a person’s nose with a swab and saline.

Testing will now be possible for those who cannot get to a collection center, including those who are home because they are ill, quarantined, or at high risk of infection due to their age or comorbidities. A Rutgers official said the new method will allow for a dramatic increase in the number of people who can be tested.

For more, visit ajmc.com.

Patient With PD Improved After Autologous Cell Transplant

A novel treatment that reprogrammed the skin cells of a single patient with Parkinson disease to replace cells in the brain improved symptoms over 24 months, but researchers cautioned that larger clinical studies will be needed to demonstrate long-term results.

In study findings published this week in The New England Journal of Medicine, researchers from McLean Hospital and Massachusetts General Hospital reprogrammed the skin cells of a 69-year-old man with a 10-year history of progressive idiopathic PD through two surgeries, one in 2017 and the other in 2018.

“Current drugs and surgical treatments for Parkinson disease are intended to address symptoms that result from the loss of dopaminergic neurons, but our strategy attempts to go further by directly replacing those neurons,” said senior author Dr Kwang Soo Kim, director of the Molecular Neurobiology Laboratory at McLean Hospital.

Imaging tests after a 2-year follow-up showed the transplanted cells are functioning as dopaminergic neurons and immunosuppresants are not required.

Since the surgery, the patient has seen improved motor skills and quality of life, although the authors say the results must be viewed with caution since the intervention was not blinded and there was no control.

Lead author Dr Jeffrey Schweitzer, a PD-specialized neurosurgeon and director of the Neurosurgical Neurodegenerative Cell Therapy program at MGH, noted that the results represent 1 patient’s experience and that a formalized clinical trial is needed to see whether others with Parkinson disease could expect similar results.

“With that said, the outcome is extremely encouraging for the future prospects of this technique,” said Schweitzer.

For more, visit ajmc.com.

Semaglutide Shows Promise in Treating NASH

In a first-quarter earnings report, Novo Nordisk announced promising initial data from a phase 2 trial testing the efficacy of glucagon-like peptide-1 agonist semaglutide, sold as Ozempic, in individuals with NASH, a condition defined as fat and inflammation in one’s liver.

There are currently no approved pharmacological treatments for NASH. Recommendations for managing the disease include diet modification, exercise, and weight loss. According to the company, the promising results are “the largest NASH resolution improvement so far.”

“Following the completion of the phase 2 trial, semaglutide in NASH is now being evaluated for further clinical trial development,” according to the report.

For more, visit ajmc.com.

Paper of the Week

Now we bring you Paper of the Week, which looks back at research and commentary of the past 25 years in The American Journal of Managed Care^® and why it matters today.

May is Mental Health Awareness Month, and a 2015 paper showed the potential for electronic health visits, or eVisits as the paper called them, to provide access to care for patients who needed immediate assistance. Authors from the University of Pittsburgh called for creating protocols that would allow “prompt attention to common mental health concerns.”

Today, in the time of COVID-19 telehealth has become the standard way to deliver both mental health and other types of care, and most believe it will remain after the pandemic if reimbursement can be arranged.

For the full paper, visit ajmc.com.

For all of us at AJMC^®, I’m Matthew Gavidia. Thanks for joining us.